Job Description

Overview

Work Flexibility: Remote

Staff Medical Writer (Remote) We are currently seeking a Staff Medical Writer to join our Sports Medicine Business Unit, part of the Stryker Endoscopy Division. In this role, you will collaborate closely with cross-functional teams, including Regulatory, Clinical, Quality, and Marketing to ensure the successful preparation of high-quality, submission-ready clinical documents. These include Clinical Evaluation Reports, Post-Market Clinical Follow-up documents, Summaries of Safety and Clinical Performance, and Clinical Study documentation.

Work Flexibility: Remote - can be based remotely anywhere within the United States.

What you will do

• Responsible for the development and completion of Clinical Evaluation Reports (CERs) and post market clinical follow-up (PMCF) documents for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs.
• Complies clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesizes the information in support of EU-MDR submissions, required CERs, and annual updates.
• Performs systematic literature reviews for medical device groups or sub-groups. Interprets literature information and synthesizes the information in clinical regulatory documents.
• Addresses notified body feedback on EU clinical documents and leads them to resolution for continued EU market access of the products.
• Collaborates cross-functionally to provide input for design teams for Clinical EU MDR documentation.
• Assists with Clinical Evaluation Strategy for EU Market access.
• For all documents, coordinates and manages the review process, and leads discussions on document revision.
• Challenges conclusions when necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all reviewers.

What you need

Basic Qualifications

• Bachelors degree (BA or BS) in a technical and/or scientific discipline required.
• 4+ years of Industry experience in medical technology or pharmaceuticals, along with 2+ years of experience in Scientific or Medical Writing, relevant academic or clinical research experience (PhD, Post-doc).

Preferred Qualifications

• Masters or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) is highly preferred
• Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software
• Knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents.
• Scientific and medical writing skills.
• Knowledge of clinical operations, risk management, regulatory submissions and US and international guidelines.
• Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation.

$87,600.00 - $186,700.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Learn more about the exciting ways our team is advancing sports medicine on our LinkedIn page:

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information.

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